BEUDAMED
    FDA Registration Active 🇻🇳 Vietnam

    Pulse Oximeter MD300CN310 PM-DC40040

    Reg #: 3018514222 · FEI: 3018514222 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUXSHARE - ICT (NGHE AN ) LIMITED
    Registration Number
    3018514222
    FEI Number
    3018514222
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.18, 03 STREET, VSIP NGHE AN INDUSTRIAL PARK, HUNG TAY COMMUNE, HUNG NGUYEN DISTRICT, NGHE AN PROVINCE, VIET
    City
    Nghe An
    Country
    VN

    Regulatory Submissions

    510(k) Number
    K161560

    Owner / Operator

    Firm Name
    LUXSHARE - ICT (NGHE AN ) LIMITED
    Operator Number
    10093365
    Address
    NO.18, 03 STREET, VSIP NGHE AN INDUSTRIAL PARK, HUNG TAY COMMUNE, HUNG NGUYEN DISTRICT, NGHE AN PROVINCE, VIET
    City
    Nghe An
    State
    VN-22
    Postal Code
    880000
    Country
    VN
    Correspondent
    Luffy H Chen

    US Agent

    Business Name
    Austin Chen
    Contact Name
    Austin Chen
    Address
    480 N. McCarthy Blvd #280
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US
    Email
    [email protected]
    Phone
    408 9570535 ext. 59174

    Products

    Device Name Product Code
    Oximeter DQA

    Proprietary Names

    Pulse Oximeter MD300CN310 PM-DC40040 Pulse Oximeter MD300C52 300A MD300C12 Pulse Oximeter 459-PUW Pulse Oximeter MD300C52-H-D2 2150 Pulse Oximeter MD300C1D 16-FTP Pulse Oximeter MD300C53 18707 Pulse Oximeter MD300C17 B240100 Pulse Oximeter MD300C15 ASP300C15 Pulse Oximeter CN360 HCSM70S Pulse Oximeter MD300C21C 081505965 Pulse Oximeter MD300C1K 500CL Pulse Oximeter MD300C12 459-BKW Pulse Oximeter MD300C12 459-GYW Pulse Oximeter MD300C12 459-ROW Pulse Oximeter MD300C634 570-3222 Pulse Oximeter MD300C12 459-REW Pulse Oximeter MD300C2J6 500C Pulse Oximeter MD300C2B 12-1927 Pulse Oximeter MD300C53-H-D2 12-1935 Pulse Oximeter MD300C12 459-HKW Pulse Oximeter MD300CN310 2711-30310 Pulse Oximeter MD300C1B 12-1926 Pulse Oximeter MD300C21C 16-93651 Pulse Oximeter MD300C52 BJ240120

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)